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Manual PPG en US
Manual PPG en US
Product Description 6
Cautions 7
Expectations 10
How Fitbit Irregular Rhythm Notifications work 10
Notifications you might see 10
Phone notification 10
Fitbit app notification 11
Operating Instructions 12
Compatible devices and System Requirements 12
Turn on irregular rhythm notifications 12
View irregular rhythm details and history 13
Delete irregular rhythm notifications 14
Turn off irregular rhythm notifications 14
Fitbit app 14
fitbit.com 14
Troubleshooting 15
Data collection 15
Data analysis 15
Receiving notifications 16
Clinical Study 17
2
What is atrial fibrillation? 17
Signs that you may have atrial fibrillation 17
Lifestyle and other factors 18
Potential treatment options 18
Terms of Service 20
3
Glossary
Atrial fibrillation (AFib) is a type of irregular heart rhythm, caused when the upper chambers
of the heart beat irregularly.
Heart rate
Your heart rate is the number of times your heart contracts (beats) in a minute. It’s often
expressed as beats per minute (bpm).
Photoplethysmography (PPG)
Pulse rate
Fitbit smartwatches and trackers have optical sensors that can detect the pulse of blood that
goes to your wrist with every heartbeat. The pulse rate is used to estimate heart rate (see
above) and to look for irregularities in beat-to-beat measurements.
Indications for Use
US*:
These data are only captured when the user is still. Along with the user’s risk factors,
the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for
AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace
traditional methods of diagnosis or treatment.
The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended
for use in people under 22 years of age. It is also not intended for use in individuals
previously diagnosed with AFib.
Non-US**:
* US Indications for Use apply to the United States and the following US territories:
American Samoa, Puerto Rico, Guam, US Virgin Islands
** Non-US Indications for Use apply to the following countries: Austria, Belgium,
Canada, Chile, Czech Republic, France, Germany, Ireland, Italy, Luxembourg,
Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, and
the United Kingdom.
This user manual is available on help.fitbit.com in the local languages for the
countries listed above.
Note that this product is not regulated as a medical device in the following
countries/regions: Hong Kong
Product Description
The Fitbit Irregular Rhythm Notifications feature is used to track and analyze pulse
rhythm data for irregularities in beat-to-beat measurements, which can be
indicative of AFib. Heart-rhythm data are temporarily stored on your consumer
wrist-worn product until the data sync to your account. If signs of AFib are found in
the data, you’ll receive a notification on your phone to view details of the findings in
the Fitbit app. The data are not analyzed in real-time and are not intended for
diagnostic purposes.
The feature can be found in the Irregular Rhythm Notifications tile within the Health
Assessments section in the Fitbit app. This tile is also used for onboarding,
displaying past results, and other non-medical device data.
Intended Clinical Benefit
The primary benefit of the Fitbit Irregular Rhythm Notifications is to analyze pulse
rate data to identify episodes of irregular heart rhythms consistent with atrial
fibrillation and to provide a notification to the user.
Cautions
The feature has not been tested for and is not intended for use in people under 22
years of age. The feature is not intended for use for people with a history or
diagnosis of atrial fibrillation.
General Warnings and Precautions
DO NOT change your medication without first speaking to your doctor. The results
of the Fitbit Irregular Rhythm Notifications may not be accurate in people who take
medication or substances that affect heart rate or blood flow.
If you receive a notification and have not been diagnosed with AFib by a physician,
you should talk to your doctor. Erroneous false negative or false positive results due
to the device or user error may occur. If you don’t get a notification, it’s possible to
still have AFib. Fitbit is not always looking for AFib. We can’t notify you for all
instances of irregular heart rhythm that may be AFib. For more information on the
performance of Fitbit Irregular Rhythm Notifications, see "Clinical Study" on
page 17.
This feature has not been tested on people with a cardiac pacemaker or implantable
cardioverter-defibrillator. If you have one of these devices, please consult with a
doctor before using this feature.
This product CANNOT detect heart attack, blood clots, stroke, or other heart
conditions.
DO NOT interpret or take clinical action solely based on the notification without
consultation of a qualified healthcare professional.
Wear your consumer wrist-worn product as instructed. For more information, see
help.fitbit.com.
A number of factors can affect the accuracy of the pulse rate data used to look for
signs of AFib, including body motion, wrist or finger movements, wrist tattoos, and
decreased blood flow to the wrist.
For security purposes, it’s recommended that you maintain control and possession
of your compatible consumer wrist-worn product and mobile devices to prevent
unauthorized access to your health data. Refer to the manufacturer’s instructions
for your mobile device to enable passcode functionality to deter unauthorized
access. Additionally, secure your Fitbit account with a strong password. For more
information, see help.fitbit.com. If available on your consumer wrist-worn product,
we recommend that you enable device lock. For more information, see
help.fitbit.com.
Phone notification
If you allow notifications from the Fitbit app on your phone, you see a notification
on your phone:
Tap View Now to see the readings where we saw signs of an irregular heart rhythm,
or tap the X icon to dismiss the notification.
Operating Instructions
Compatible devices and System Requirements
Irregular Rhythm Notifications are available on:
If an incompatible device is paired after the user has consented to the feature, the
algorithm will not analyze data from an incompatible device.
The Fitbit app requires iOS 15.5 or higher or Android 12 or higher. For additional
information on device compatibility with the Fitbit app, see
fitbit.com/global/us/technology/compatible-devices.
Note that the Fitbit Irregular Rhythm Notifications is only available in select
locations at this time. Additional devices & countries will be added as regulatory
clearance is obtained. See fitbit.com/irregular-rhythm for additional details.
1. From the Discover tab in the Fitbit app on your phone, tap Assessments &
Reports.
2. Tap the Irregular Rhythm Notifications tile.
3. Tap Set Up Now, and follow the on-screen instructions.
1. From the Today tab in the Fitbit app on your phone, tap your profile
picture.
2. Tap Activity & Wellness Heart Settings Irregular Rhythm.
3. Tap Turn off this feature Turn off.
fitbit.com
1. Using a web browser, open fitbit.com/afib-notifications/settings. If prompted,
log in to your Fitbit account.
2. Tap Turn off this feature.
Troubleshooting
Data collection
Fitbit can only analyze your heart rhythm data for AFib when you’re still. Wear your
consumer wrist-worn product often, especially to sleep, and sync your data often to
help look for signs of AFib more often. We only send a notification if we see signs of
an irregular rhythm in multiple readings, which means you might not receive
irregular rhythm notifications if we’re not able to collect enough data each day.
Data analysis
Fitbit doesn’t analyze your data in real-time. Keep the Fitbit app running in the
background to make sure your compatible watch or tracker can regularly sync. To
check when your heart rhythm data was last analyzed:
1. From the Discover tab in the Fitbit app on your phone, tap Assessments &
Reports.
2. Tap the Irregular rhythm notifications tile. The time and date when your data
was last analyzed appears below your history of notifications.
Note that data is stored on your consumer wrist-worn product for 7 days. If you
haven’t synced with the Fitbit app in over 7 days, older data might be deleted and
won’t be analyzed.
Receiving notifications
If your phone doesn’t receive push notifications from the Fitbit app:
l Turn on notifications for the Fitbit app in your phone's settings. For
instructions, see support.google.com for Android phones or
support.apple.com for iPhones.
l Check that the Fitbit app on your phone is updated. For instructions, see
help.fitbit.com.
Clinical Study
A clinical study was performed to validate the Fitbit Irregular Rhythm Notifications
(IRN) software algorithm’s ability to detect atrial fibrillation (AFib) using data
collected from consumer wrist-worn products. The Fitbit Validation of Software for
Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable
Smartwatch Study (NCT04380415) included 455,699 subjects. There were 4,728
subjects who received an irregular rhythm notification and were invited to receive
and wear an electrocardiogram (ECG) patch. Of those, 1,057 wore and returned a 7-
day ECG patch monitor with usable data. The prevalence of AFib based on the 7-
day ECG patch monitoring results was 32.2% (340/1057).
The Fitbit Irregular Rhythm Notifications software algorithm detected signs of AFib
in 225 subjects while they were wearing an ECG patch after an initial IRN
notification. Of those, 98.2% (221/225) showed AFib detections from the Fitbit
Irregular Rhythm Notifications software algorithm and the ECG patch at
approximately the same time. No serious adverse events were observed during the
clinical study.
l Advanced age
l High blood pressure
l Obesity
l European ancestry
l Diabetes
l Heart failure
l Ischemic heart disease
l Hyperthyroidism
l Chronic kidney disease
l Heavy alcohol use
l Enlargement of the chambers on the left side of the heart
l Medication
l Surgery
l Lifestyle changes
Learn more from the CDC [https://www.cdc.gov/], American Heart Association
[https://www.heart.org/], or by visiting the website of the European Society of
Cardiology [https://www.escardio.org/].
Terms of Service
Fitbit designs products and tools that help you achieve your health and fitness
goals and empower and inspire you to lead a healthier, more active life. These
Terms of Service (“Terms”) apply to your access and use of the Fitbit Service. The
“Fitbit Service” includes our devices including associated firmware, applications,
software, websites, APIs, products, and services.
If you live in the European Economic Area, the United Kingdom or Switzerland,
these Terms are an agreement between you and Fitbit International Limited, an Irish
company with its registered office at 76 Lower Baggot Street, Dublin 2, Ireland. If
you reside elsewhere, these Terms are an agreement between you and Fitbit LLC,
199 Fremont Street, 14th Floor, San Francisco, CA 94105 U.S.A. When the Terms
mention “Fitbit,” “we,” “us,” or “our,” they refer to the party to your agreement that
provides you with the Fitbit Service.
You must accept these Terms to create a Fitbit account and to access or use the
Fitbit Service. If you do not have an account, you accept these Terms by using any
part of the Fitbit Service. If you do not accept these terms, do not create an
account, or use the Fitbit Service.
Fitbit LLC
199 Fremont St.
Emergo Europe MedEnvoy Switzlerland
14th Floor
Prinsessegracht 20 Gotthardstrasse 28
San Francisco, CA 94105
2514 AP The Hague 6302 Zug
United States
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www.fitbit.com
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